GP prescribing errors are ‘common’, report says

by JoelLane 2. May 2012 15:20

Pf clinical news One UK patient in six is affected by incorrect GP drug prescriptions each year, according to a General Medical Council review.

The most common type of error was incomplete information, followed by dosage errors and the timing of doses.

The GMC recommended that GP consultations be extended from 10 to 15 minutes, and called for improvements in checking and better use of IT.

The study examined 6,046 prescription items for 1,777 patients. It found that 1 in 20 were incorrectly prescribed or monitored, amounting to at least one error per year for 18% of patients.

Risk factors for prescription errors included age (over 65 or under 15) and multiple prescription items, as well as the following therapy areas: cardiovascular, infection, cancer, immunosuppression, musculoskeletal, eye, skin and ENT.

Only 4% of prescription items were associated with a ‘severe’ error, and it was noted that pharmacy staff would have corrected many of the minor errors.

The ‘severe’ errors included patients being given drugs they were allergic to, and poor monitoring of potentially dangerous drugs such as warfarin.

The report concluded that “prescribing errors in general practices are common, although severe errors are unusual.”

Katherine Murphy of the Patients’ Association commented: “It is deeply worrying that such dangerous mistakes are being made. Patient safety is paramount yet still these avoidable errors are slipping through the net.”

Lipitor losses continue to hit Pfizer

by IainBate 2. May 2012 15:03

Pharma Industry News Pfizer continued to suffer from generic exposure on its former cholesterol blockbuster Lipitor in Q1 2012 after overall sales and earnings both dropped.

Reported revenues fell 7% to $15.4bn and net income decreased by nearly a fifth (19%) after sales of Lipitor fell by almost half (42%) to just under $1.4 billion.

Ian Read, Pfizer Chairman and CEO, said he was “pleased” with the results after witnessing growth in “certain brands” and “key geographies”.

Biopharmaceutical sales decreased 8% to just over $13bn as revenue for Lipitor in the US dropped by nearly three-quarters (71%) to $383 million.

Sales of Prevenar 13 dropped by 6% to $941m, Xalatan fell by 42% to $227m with Novasc also recording a fall in revenue by 6%, compared to the same period last year.

The news was better for Lyrica up 16% to $955m, whilst Enbrel earned $899 million outside the US and Viagra generated a 6% rise in sales to earn $496m.

As a result of the losses, Pfizer has adjusted its revenue guidance for the full year from $60.5-$62.5 billion to $58-$60 billion.

Frank D’Amelio, Chief Financial Officer, said the adjustment reflects Pfizer’s recent $11.58 deal with Nestlé for its nutrition business. He commented: “We remain on-track to finalise a strategic decision for our Animal Health business this year and continue to expect that any separation of that business will occur between July 2012 and July 2013.

“Further, this quarter we continued to prudently allocate our capital by returning over $3.3 billion to our shareholders in first-quarter 2012, through $1.6 billion in dividends and $1.7 billion from the repurchase of 77 million shares.”

GSK infant meningitis vaccine approved in EU

by JoelLane 2. May 2012 15:02

Pf product news The European Commission has approved GSK’s vaccine Nimenrix for treatment of meningitis in young children.

The vaccine offers protection against a highly contagious strain of meningitis to which children in the first four years of life are particularly susceptible.

Nimenrix is the first form of immunisation against invasive meningococcal disease to have EU approval for use in children as young as 12 months.

Given in a single dose, Nimenrix protects against Neisseria meningitidis serogroups A, C, W-135 and Y, which can cause deafness, epilepsy and death.

According to the WHO, this strain of meningitis uniquely has the potential to cause major epidemics: the bacteria, carried in the throat, are spread by coughing and can invade the brain.

Sanofi Pasteur’s Menactra offers protection against the same strand and is approved for use in infants in the US, but is not available in Europe; while Novartis’ Menveo is only approved for people aged 11 years and above in Europe.

Thomas Breuer, Head of Global Vaccine Development at GSK, commented: “GSK is pleased to have received approval in Europe for Nimenrix and looks forward to making this vaccine available to help protect individuals against what can be a life-threatening disease.”

New CEO at Verona Pharma

by JoelLane 2. May 2012 14:46

Pf industry news UK biotechnology company Verona Pharma has appointed an experienced industry leader, Dr Sven Jan-Anders Karlsson, as its new CEO.

Dr Karlsson replaces Verona’s co-founder Michael Walker, who is stepping down as CEO but will remain as a senior scientific advisor.

The new CEO has widespread leadership experience in the life science industry, with roles including director at biotech company S*BIO, executive VP of pharmaceutical global research at Bayer HealthCare, and senior positions at Rhone-Poulenc Rorer and Astra.

Verona’s Chair, Professor Clive Page, commented: “We have taken time to identify and recruit the right person to take over from Michael after he had notified the Board of his intention to step down.

“We believe Jan-Anders’ experience in the pharmaceutical and biotechnology sector will be invaluable to Verona Pharma as we move our clinical programmes forward, and continue to grow and expand the company.”

Based in London, Verona Pharma is a biotechnology company that specialises in developing new medicines for chronic respiratory diseases.

Lexapro sales hit Lundbeck Q1 results

by IainBate 2. May 2012 14:16

Lexapro sales hit Lundbeck Q1 results - Pharmaceutical Field Revenue fell at Lundbeck by 8% in Q1 2012 after price reductions and generic competition on Lexapro reduced sales to DKK 3.7bn.

Sales in the US were down by nearly a third (30%) and in Europe by 6% after Lexapro lost patent protection and saw profits drop by DKK 320m, compared to Q1 2011.

Ulf Wiinberg, Lundbeck’s President and CEO, said that despite the losses the company is “off to a good start for the year and on track to meet our expectations”.

Lundbeck has maintained its guidance for 2012 and expects revenue to be in the region of DKK 14.5 to 15.2 billion.

Excluding sales of Lexapro in the US, Lundbeck recorded an increase in revenue of 2%. Sales of the anxiety drug dropped from DKK 741 in Q1 2011 to DKK 336 in the first three months of the year.

Sales of Cipralex were heavily impacted by generic competition in Spain as revenue fell by 4% to DKK 1.47bn. However, this was compensated by increased sales of Xenazine (35%), Sabril (14%) and Ebixa (11%).

Growth was recorded in International Markets where revenue was up 15% and in the US – excluding sales of Lexapro – by 18% compared to Q1 2011.

Lexapro was recently launched in Japan and Lundbeck says the drug holds a market share of 3.4%. It hopes to build on this and launch a number of new products in the next 18 months.

“We are on track with the diversification of our product portfolio, with the three recent launches of Lexapro in Japan, Sycrest and Onfi,” said Ulf Wiinberg. “During the next 1½ years we will potentially launch four additional products.”

Wet AMD drug controversy fuelled by new study

by JoelLane 2. May 2012 12:33

Lucentis resized The controversy over whether Avastin can replace Lucentis as a treatment for wet AMD has intensified following the publication of a major clinical study.

The CATT study, a head-to-head comparison of the two injectable drugs, suggests that Avastin is comparable to the more expensive Lucentis in terms of clinical efficacy.

However, the study also highlights that Avastin may increase the risk of major adverse events such as blood clots and congestive heart failure.

Roche’s Avastin (bevacizumab) is not licensed for treatment of the eye disorder wet AMD, which affects many elderly people, in Europe or the USA.

However, its off-label use has become widespread because it is much cheaper than the standard treatment, Roche’s Lucentis (ranibizumab) – which is marketed outside the US by Novartis.

In the UK, Lucentis (which costs £890 per dose) is the only NICE-approved treatment for wet AMD, but some PCTs recommend the use of Avastin (at £50–100 per dose) to save money.

Novartis is currently seeking a judicial review of the recommendation of Avastin for wet AMD by one PCT cluster.

The two-year Comparison of Age-related macular degeneration Treatment Trials (CATT), carried out by the National Eye Institute in the US, has concluded that both drugs offer “robust and lasting” improvements in vision.

However, those patients taking Avastin show a higher incidence of serious adverse events (40%) than those taking Lucentis (32%). The high figures reflect the median age (over 80) of the study participants.

The adverse events recorded include arterial and venous blood clots, haemorrhagic stroke, congestive heart failure and vascular death

The study authors concluded: “The choice of drug and dosing regimen for patients must balance the comparable effects on vision, the possibility of true differences in adverse events, and the fortyfold difference in cost per dose.”

However, Novartis has drawn attention to the adverse event data, arguing that “it would be inappropriate to advocate use of unlicensed bevacizumab for wet AMD, on the basis of these trials,” and further noting that of the two drugs, only Lucentis was specifically designed for use in the eye.

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News

NHS Confed chair to lead new training body

by IainBate 2. May 2012 11:19

NHS Confed chair to lead new training body - Pharmaceutical Field Sir Keith Pearson, NHS Confederation Chairman, will stand down from his role after being appointed as the first Chair of the newly established Health Education England.

The body will provide national leadership to the new system of education and training in healthcare when it is established towards the end of June 2012.

Mike Farrar, NHS Confed Chief Executive, said Sir Keith has been a “great asset” to the Confederation “which has gone from strength to strength under his leadership”.

The outgoing chair will start his new role on 28 June 2012 at the new education and training organisation.

He commented that he was “delighted” with his new role and was proud of his achievements whilst serving the NHS Confederation. “We have forged closer links with our members, improved the way we develop and deliver our services to provide increased value for money, and secured and strengthened our financial future,” he said. “I know the NHS Confederation will build on these firm foundations to deliver exceptional support for members in the coming year.”

“It is great to see him taking his expertise to Health Education England to ensure the future health workforce is equipped to deliver high quality care for patients and service users,” said Mike Farrar.

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